Extractables & Leachables Testing of Large Molecule Drug Forms

Description

Summary: Large Molecule drugs, Biopharmaceuticals, or Biologics are a growing class of drugs in the Pharmaceutical industry. These drug forms include pharmaceutical products that are manufactured in, extracted from, or synthesized from biological sources. These drug forms offer the ability to treat medical conditions that traditional “small molecule” drug forms cannot. Biologics are comprised of living cells, proteins, tissues, blood components, vaccines, or gene therapies. The requirements for characterizing these drug forms during development and manufacture is the same as for small molecule drugs. This includes the evaluation of extractables and leachables for the container closure system and/or delivery system. Due to the nature of biologics, most are administered through injection or other parenteral route. The U.S. Food and Drug Administration (FDA) Guidance for Industry has categorized parenteral drug forms as having a high concern associated with the route of administration. The FDA has specifically requested leachables studies be performed for parenteral products. Leachables testing involves analyzing the drug product during storage in its container closure system for leachable compounds from the container closure system materials. Developing appropriate leachables methods for characterizing biologic drug forms presents many challenges over small molecule drug forms. Boston Analytical will present our experience working with these challenging materials, as well as strategies for conducting E&L studies.
 
Presenter: Mike Molloy, Technical director of the Biologics Laboratory and Eric Hill, Director of the Extractables & Leachables Laboratory
 
Mike's Bio: Mike Molloy has been with Boston Analytical since 2012, serving first as the Director of the QC Chemistry laboratory, then heading Analytical Development in Chemistry and most recently serving as the Technical director overseeing the Biologics Laboratory. Prior to joining Boston Analytical, he spent twenty years in pharmaceutical development at Biogen, developing bioassays for product characterization and methods for bioanalysis of clinical trial  pharmacokinetics samples. Molloy was head of laboratory operations in the Preclinical and Clinical Developments Sciences group at Biogen. Mike holds a master’s degree in biology from Umass Lowell and a bachelor’s in biology from UNH.
 
Eric's Bio: Eric Hill joined Boston Analytical in 2014 as Director of the Extractables & Leachables laboratory. Prior to Boston Analytical, Eric spent 15 years at a contract analytical laboratory in various roles including Analytical Scientist, Business Development Manager, Business Manager, and finally President. Eric has an extensive background in polymer material characterization, and contributes to industry groups and technical conferences in the E&L space. He holds a bachelor’s degree in chemistry from the University of Michigan, a master’s degree in analytical chemistry from Central Michigan University, and an M.B.A. from the University of Michigan.